Effects of nutritional interventions during pregnancy on birth, child health and development outcomes: A systematic review of evidence from low‐ and middle‐income countries

Abstract Background Optimal nutrition plays a crucial role in pregnancy. Poor maternal nutrition and maternal obesity has risk factors for serious fetal complications and neonatal outcomes, including intrauterine growth restriction, congenital abnormalities, stillbirth, low birth weight (LBW), preterm birth, fetal macrosomia, increased risk of neonatal infections, neonatal hypothermia, and neonatal death. The prevalence of maternal malnutrition is higher in low‐ and middle‐income countries (LMICs) (10–19%) when compared with high‐income countries, with variation by region and by country. Several behavioral interventions, including dietary control and exercise, have been found to reduce the risk of these adverse outcomes. However, none has reviewed dietary interventions to prevent maternal obesity in pregnant women. Objectives The review aims to assess the effectiveness of balanced energy protein (BEP) supplementation, food distribution programs (FDPs), and dietary interventions to prevent maternal obesity during pregnancy on birth, child health, and developmental outcomes. Search Methods We searched Cochrane Controlled Trials Register (CENTRAL), MEDLINE, Embase, CINAHL, and 12 other databases, and trials registers for ongoing studies up until April 2019. We also searched for gray literature from different sources and for citations on Google Scholar and Web of Sciences. We also checked the reference lists of included studies and relevant reviews and contacted the authors of studies for any ongoing and unpublished studies. The search was followed by title/abstract screening, full‐text screening and data extraction. Selection Criteria We included randomized control trials, and quasi experimental trials to evaluate the impact of nutritional interventions (BEP, FDP, and dietary interventions to prevent maternal obesity) compared to control or standard of care, among healthy pregnant women of any age living in LMICs. Data Collection and Analysis Two review authors independently assessed and screened studies for eligibility, extracted data, and assessed quality of the studies included in the review. We conducted a meta‐analysis of all reported primary and secondary outcomes. Subgroup analysis and GRADE assessment was performed for all reported primary outcomes. Main Results The review included 15 studies, of these, eight were on BEP supplementation, five on FDP, and two on interventions for obesity prevention. BEP supplementation may show a reduction in the rate of stillbirths by 61% (risk ratio [RR], 0.39; 95% CI, 0.19–0.80; three studies, n = 1913; low quality on GRADE), perinatal mortality by 50% (RR, 0.50; 95% CI, 0.30–0.84; one study, n = 1446; low quality on GRADE), LBW infants by 40% (RR, 0.60; 95% CI, 0.41–0.86; three studies, n = 1830; low quality of evidence on GRADE); small for gestational age (SGA) by 29% (RR, 0.71; 95% CI, 0.54–0.94; five studies, n = 1844) and increased birth weight by 107.28 g (mean difference [MD], 107.28 g; 95% CI, 68.51–146.04, eight studies, n = 2190). An increase of 107.28 g of birthweight is clinically significant in the countries where the intervention was provided. BEP supplementation had no effect on miscarriage, neonatal mortality, infant mortality, preterm birth, birth length, and head circumference. FDP may show improvement in mean birth weight by 46 g (MD, 46.00 g; 95% CI, 45.10–46.90, three studies, n = 5272), in birth length by 0.20 cm (MD, 0.20 cm; 95% CI, 0.20–0.20, three studies, n = 5272), and reduction in stunting by 18% (RR, 0.82; 95% CI, 0.71–0.94; two studies; n = 4166), and wasting by 13% (RR, 0.87; 95% CI, 0.78–0.97; two studies, n = 3883). There was no effect of FDP on miscarriage, maternal mortality, perinatal mortality, neonatal mortality, infant mortality, preterm birth, LBW, SGA, head circumference, and underweight babies. Studies on interventions for obesity prevention among pregnant women failed to report on the primary outcomes. The studies showed a 195.57 g reduction in mean birth weight (MD, −195.57 g, 95% CI, −349.46 to −41.68, two studies, n = 180), and had no effect on birth length, and macrosomia. Authors' Conclusions Our review highlights improvement in maternal, birth, and child outcomes through BEP supplementation and FDP during pregnancy. But, due to the small number of included studies and low quality of evidence, we are uncertain of the effect of BEP supplementation, FDP and dietary interventions for prevention of obesity on maternal, and child outcomes. Thus, further good quality research is recommended to assess the effect of these interventions on maternal, child and developmental outcomes.

the effectiveness of BEP supplementation, FDPs, and dietary interventions to prevent maternal obesity during pregnancy.

What is the aim of this review?
This Campbell systematic review summarises the evidence from 15 studies of the effect of nutritional interventions for pregnant women on maternal and infant health outcomes.

| What studies are included?
Eligible studies had to be randomized control trials (RCTs) or quasiexperimental trials to evaluate the impact of nutritional interventions (BEP, FDP, and dietary interventions to prevent maternal obesity) compared to control or standard care, among healthy pregnant women of any age living in low-and middle-income countries (LMICs).
Fifteen studies are included in the review. Of these, eight were on BEP supplementation, five on FDP, and two on interventions for obesity prevention. The included studies are mainly from Asia (seven studies) and Africa (six studies).

Do the interventions work?
Overall, BEP and FDP have a positive effect on selected maternal and infant outcomes, but not on others. Obesity prevention programs may beneficially reduce birth weight, with no effect on other outcomes. In all cases, the evidence is of low to moderate quality.
BEP supplementation. BEP supplementation may show a reduction in the rate of stillbirths, perinatal mortality, low birth weight (LBW), babies who are SGA, and an increase in birth weight of 107.3 g which is clinically significant in the countries where the intervention was provided.
BEP supplementation had no effect on miscarriage, neonatal mortality, infant mortality, pre-term birth, birth length, and head circumference.
Food distribution programs. FDP may reduce stunting and wasting and improve mean birth weight by 46 g as well as birth length by 0.20 cm.
There was no effect of FDP on perinatal mortality, miscarriage, maternal mortality, neonatal mortality, infant mortality, preterm birth, LBW, small for genstational age, head circumference, or underweight babies.
Obesity prevention. Obesity prevention was associated with a 195.6 g reduction in mean birth weight but not macrosomia (the proportion of babies much larger than average for their gestational age) or birth length.
Studies on interventions for obesity prevention among pregnant women did not report other outcomes such as miscarriages and mortality.
1.3 | What do the findings of this review mean?
Our review highlights improvement in selected maternal, birth, and infant outcomes through BEP supplementation and FDP during pregnancy, though not on others. However, due to the small number of included studies and low quality of evidence, we are uncertain of the effect of BEP supplementation, FDP and dietary interventions for prevention of obesity on maternal, and infant outcomes. Thus, further good quality research is recommended to assess the effect of these interventions on maternal, infant and developmental outcomes. obesity increases the risk of fetal macrosomia, stillbirth, congenital obesity (Alfaradhi & Ozanne, 2011;Catalano & DeMouzon, 2015;Stothard et al., 2009), and infant mortality (Meehan et al., 2014).
The prevalence of maternal malnutrition is higher in LMICs when compared to high-income countries . Malnutrition refers to a group of nutritional disorders that include micronutrient deficiencies, under-nutrition, and overweight/obesity. Maternal undernutrition is typically defined by a body-mass index (BMI) <18.5 kg/m 2 , while overweight is classified as BMI ≥ 25 kg/m 2 and obesity as BMI ≥ 30 kg/m 2 . The double burden of malnutrition is the co-existence of under-nutrition, overweight, and obesity, which has also been found to be highly prevalent in LMICs (Kimani-Murage et al., 2015) due to diets that chronically lack diversity and infections and/or chronic disease that could contribute to deficiencies by directly inhibiting nutrient absorption.
The prevalence of maternal under-nutrition ranges from 10% to 19% in LMICs, with variation by region and by country . In addition, more than 10% of women aged 15-45 years living in LMICs have heights (i.e., maternal stunting defined as maternal height <145 cm) that are considerably below the average . The prevalence of low BMI in adult women is more than 20% in Sub-Saharan Africa and South-Central and Southeastern Asia . Some individual countries are worse than others.
For example, in India, the prevalence of under-nutrition among women of reproductive age reaches almost 40% . In 2014, about 1.9 billion adult people worldwide were found to be overweight, a prevalence that surpassed that of underweight, which constituted about 462 million people. In addition, more than 600 million were reported to be obese (WHO, 2017). The prevalence of obesity is higher in the Americas and the Caribbean when compared to Africa, but overall, rates of overweight and obesity are rising globally, a situation that mimics that in high-income countries and may be reflective of changing food environments WHO, 2017).
Both maternal under-and over-nutrition can have adverse effects before, during, and after pregnancy (Kimani-Murage et al., 2015). Maternal under-nutrition throughout pregnancy has also been associated with long-term health issues for the infant, such as obesity, diabetes mellitus, hypertension, and cognitive dysfunction (Crispi et al., 2018;Maršál, 2018). In addition, LBW has been associated with increased risk of death from coronary heart disease and stroke in adulthood (Crispi et al., 2018). Malnutrition or inadequate dietary intake during pregnancy can expose the fetus to a harsh environment, which forces the fetus to adapt. However, this adaptation can lead to permanent changes in function and structure that can later lead to chronic diseases in adult life (Crispi et al., 2018;Maršál, 2018). Maternal obesity has also been associated with higher risk of stillbirth and congenital abnormalities (Alfaradhi & Ozanne, 2011;Stothard et al., 2009). In addition, obesity during pregnancy is associated with increased risk of fetal macrosomia (Catalano & DeMouzon, 2015), which could lead to obstructed labor, and preterm birth, which is a major risk factor for infant mortality (Meehan et al., 2014). This review will focus on macronutrient supplementation during pregnancy. Micronutrient supplementation is being evaluated in a separate Campbell review of this series.

| Description of the intervention
Several macronutrient supplementation interventions have been proposed to address maternal malnutrition especially in LMICs including balanced energy supplementation (BEP), food provision and distribution, and dietary intervention to prevent maternal obesity Imdad & Bhutta Zulfiqar, 2012).
In LMICs, diets often lack foods rich in macronutrients and micronutrients that are typically found in meat, poultry, and fish (Gibson & Hotz, 2018). Therefore, it is important to increase the availability of macronutrients and micronutrients by promoting and introducing diverse crops, integrating farming systems with small livestock, promoting fish farming, and promoting better food storage (Gibson & Hotz, 2018). In addition, this intervention includes supplementation, which is designed to supply pregnant women in LMICs with multiple micronutrients (Allen et al., 2006;Gibson & Hotz, 2018;Zerfu et al., 2016). Such interventions have been found to be positively related to a reduced risk of maternal anemia, preterm birth, and LBW in a single study in Ethiopia (Zerfu et al., 2016).
A BEP supplement is a macronutrient food-based supplement where proteins provide <25% of total energy content (Imdad & Bhutta Zulfiqar, 2012). BEP supplements, therefore, come in several forms. For example, a study from India provided supplements that consisted of dehusked sesame cake, jaggery, and oil containing 30 g of proteins and 417 kcal energy for undernourished pregnant women (Girija et al., 1984). In another study from Gambia, undernourished pregnant women were given daily supplements of high energy biscuits made with roasted nuts, rice flour, sugar, and groundnut oil as supplements that contained 4250 kJ energy, 22 g of proteins, 56 g fat, and vitamins, and minerals (Ceesay et al., 1997).
Two previous reviews have demonstrated the positive association of BEP interventions with pregnancy outcomes, such as reduced risk of stillbirth and small for gestational age (SGA) babies, and increase of birth weight (Imdad & Bhutta Zulfiqar, 2012;Ota et al., 2015).
Food distribution programs (FDPs) provide low-income and undernourished pregnant and nonpregnant women and children with access to supplemental nutritious foods and often nutrition education (Baqui et al., 2008;Heaver, 2002;Kapil et al., 1992). These programs are typically run by local or international organizations. For example, India has the Integrated Nutrition and Health programme (INHP), which is a nongovernmental organization-based program that is implemented together through CARE-India and the Indian government (Baqui et al., 2008). This program educates pregnant women alongside the provision of healthcare services and supplementary nutrition, with the aim of increasing knowledge about maternal and newborn care, and the long-term goal of reducing neonatal mortality (Baqui et al., 2008;Kapil, 2002). India also has the Tamil Nadu Integrated Nutrition Program (TINP), which is implemented by the state government of Tamil Nadu and supported by the World Bank. TINP aims to reduce maternal and child malnutrition through the use of a Community Nutrition Centre that makes supplementary nutrition available to pregnant women and children in villages (Heaver, 2002). In Bangladesh, the nutrition-focused Maternal, Neonatal, and Child Health (MNCH) program supports pregnant women by providing several cross-cutting services such as counseling on nutrition and health, micronutrient supplementation, and weight-gain monitoring (Nguyen et al., 2017).
As noted above, obesity during pregnancy is associated with a host of maternal and fetal complications such as pre-eclampsia, caesarian birth, macrosomia and congenital malformations (Dodd et al., 2008;Muktabhant et al., 2015). Several behavioral interventions, including dietary control, and exercise, have been found to be positively related to a reduced risk of macrosomia, cesarean delivery, and gestational weight gain (GWG; Catalano & DeMouzon, 2015;Dodd et al., 2008;Guelinckx et al., 2010;Muktabhant et al., 2015;Renault et al., 2014). Interventions can vary, and could include light to moderate-intensity exercise, strength training, stretching, and relaxation exercises to prevent excessive weight gain (Nascimento et al., 2011) or combined dietary control and exercise interventions whereby diet counseling and advice is paired with exercise. However, in this review we will only focus on dietary interventions to prevent maternal obesity.

| How the intervention might work
Inadequate maternal nutritional status at contraception and during pregnancy can result in adverse birth and child outcomes. Appropriate energy intake, such as BEP supplementation, and dietary education to pregnant women can lead to maternal weight gain, and increase in fetal growth (Viswanathan et al., 2008). Protein comprising 10-15% of dietary energy (Garlick & Reeds, 2000), and BEP supplementation which provides <25% of the total energy content has shown significant beneficial impact on maternal and perinatal birth outcomes such as improved birthweight (Ota et al., 2015), and reduction in stillbirths (Imdad & Bhutta Zulfiqar, 2012;Ota et al., 2015), and SGA births (Ota et al., 2015).
FDP directly provide nutritious foods or supplements to vulnerable populations, including pregnant women. There is some evidence to support the targeting of programs to pregnant women through the subsequent improvement in birth weight and reduction of infant mortality among infants of recipient mothers (Frith et al., 2015). Often, programs will provide pregnant women with healthy foods along with access to additional services, such as nutrition counseling. Counseling sessions may include information on the components of a healthy diet, the importance and consequences of poor nutrition, and food demonstrations, which provide women with the tools and knowledge necessary to maintain good antenatal health (Nguyen et al., 2017). Other interventions use community platforms, such as community health centers, to provide services such as immunization, promotion of maternal and neonatal care, and distribution of food supplements. These strategies have been shown to reduce neonatal deaths and improve maternal anemia (Baqui et al., 2008;Leroy et al., 2016).
Lifestyle interventions that include dietary control, exercise and behavioral change have been associated with a reduced risk of excessive GWG and macrosomia and decreased risk of adverse pregnancy outcomes (Catalano & DeMouzon, 2015;Dodd et al., 2008;Guelinckx et al., 2010;Muktabhant et al., 2015;Renault et al., 2014). Moreover, lifestyle interventions for maternal obesity can be implemented using a combination of dietary control and physical activity (Renault et al., 2014) or diet and exercise and behavioral change alone (Muktabhant et al., 2015;Nascimento et al., 2011). Dodd et al. (2014) used a comprehensive antenatal dietary and lifestyle counseling intervention for pregnant women in Australia. The intervention included exercise, home visits that provided dietary advice, and behavioral strategies delivered by a registered dietician (Dodd et al., 2014).

| Why it is important to do this review
Several reviews have been published that examine the impact of the interventions described above Gibson & Hotz, 2018;Imdad & Bhutta Zulfiqar, 2012;Muktabhant et al., 2015;Ota et al., 2015;Zerfu et al., 2016). However, most of these reviews focused on the efficacy of these interventions using randomized trials and did not address the question of effectiveness of large-scale nutrition programs. Studies of effectiveness are needed to understand whether an intervention will be impactful in a real-world setting.
Additional studies have been published recently (Devi et al., 2017;Dwarkanath et al., 2016;Huseinovic et al., 2017;Saville et al., 2018), indicating a need to update the systematic review evidence. Dietary interventions alone to prevent maternal obesity during pregnancy have not been reviewed previously. Therefore this review will make a first attempt to study its evidence. Furthermore, previous reviews did not assess the long-term effects of these interventions during childhood. Taken together, this review will incorporate the latest evidence from RCTs and nonrandomized trials, and also assess the long-term effects of maternal nutritional supplementation ( Figure 1).

| OBJECTIVES
This review aims to assess the effectiveness of nutritional interventions during pregnancy on maternal, neonatal, and childhood outcomes. The specific objectives are to assess the effectiveness of the following interventions during pregnancy on birth, child health, and 1. Randomized controlled trials (RCTs), where participants were randomly assigned, individually or in clusters, to intervention, and comparison groups. Cross-over designs were eligible for inclusion.
2. Quasi-experimental designs, which include: a. Natural experiments: studies where nonrandom assignment was determined by factors that are out of the control of the investigator. One common type includes allocation based on exogenous geographical variation.
b. Controlled before-and-after studies (CBA), in which measures were taken of an experimental group and a comparable control group both before and after the intervention. We also ensured that appropriate methods were used to control for confounding, such as statistical matching (e.g., propensity score matching, or F I G U R E 1 Conceptual framework for maternal nutrition interventions covariate matching) or regression adjustment (e.g., difference-indifferences, instrumental variables).
c. Regression discontinuity designs; here, allocation to intervention/ control was based upon a cut-off score. d. Interrupted time series (ITS) studies, in which outcomes were measured in the intervention group at least three time points before the intervention and after the intervention.

| Types of participants
This review includes healthy pregnant women of any age living in LMICs, as defined by the World Bank. Studies where women were recruited in the preconception period were eligible, given that women are followed throughout pregnancy. In this review, we considered women who were undernourished (inadequate nutrition) and obese women who had no other co-morbids. We excluded all the studies conducted in high income countries. In case of multicountry studies, we planned to include data of studies conducted in LMIC only, but we did not encounter any such studies.

| Types of interventions
This review includes the following interventions that target pregnant women: 1. BEP supplementation: defined as a food supplement where proteins provide <25% of the total energy content (Imdad & Bhutta Zulfiqar, 2012

Comparison groups
Comparison groups include standard of care (routine diet).
Each intervention was summarized separately and was not compared to each other directly.

| Types of outcome measures
This review includes studies that have the following primary and secondary maternal outcomes, fetal outcomes, newborn, and child outcomes.

Maternal outcomes
• Body mass index

Fetal and newborn outcomes
Mortality: • Miscarriage defined as spontaneous expulsion of a human fetus before it is viable and especially between the 12th and 28th week of gestation • Stillbirth defined as baby born with no signs of life at or after 28 weeks' gestation (WHO, 2020) • Perinatal mortality is defined as stillbirth and deaths ≤7 days • Neonatal mortality (death <28 days)

Child outcomes
• Infant mortality (deaths between 0 and 12 months) • Under-five mortality (deaths between 0 and 59 months)

Maternal outcomes
Morbidity: • Maternal mortality defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of cause.
• Pre-eclampsia as defined by trial authors
Studies were excluded if they have not reported the outcomes mentioned above.
Duration of follow up. We included all participants in eligible studies that had outcomes of interest measured. There were no restrictions based on duration of exposure, duration of follow-up, or timing of outcome measurement. If outcomes were reported at multiple time points of follow-up, we included outcomes based on definitions of outcomes, that is, neonates (0-28 days) versus infants (0-12 months), and so forth. Where the time of follow-up was not clearly given, we contacted the authors for the missing information. For childhood and adulthood outcomes, we included the outcome at the longest follow-up.
Type of settings. We included studies from LMIC. These countries are defined as those with a gross national income (GNI) per capita of USD 1005 or less in 2016, and lower middle-income economies are those with a GNI per capita between USD 1006 and 3955 in 2016.

| Search methods for identification of studies
We did not impose any restrictions on language, date, publication status, and on the literature searches described below. We also searched for any relevant retraction statements, and errata for information.

| Electronic searches
We performed searches in April 2019 on the following electronic databases:

| Searching other resources
We made every effort to contact relevant organizations and experts in the field to identify unpublished or ongoing studies. We also searched for citations at Google Scholar and Web of Sciences. References of the included articles, and relevant reviews, were scanned for eligible studies. We also searched for gray literature on: • Nutrition International (NI) • Global Alliance for Improved Nutrition (GAIN) • World Food Programme (WFP) • United Nations International Children's Emergency Fund (UNICEF) • Emergency Nutrition Network (ENN) • International Food Policy and Research Institute (IFPRI) • WHOLIS (WHO library database) • WHO Reproductive Health Library We also searched the reference section of the previously published included studies and systematic reviews and contacted the authors of studies and other experts in case of any missing information.

| Data collection and analysis
We conducted data collection and analysis in accordance with the

| Criteria for determination of independent findings
Before initiating the synthesis (detailed below), we ensured that all articles reporting on the same study were appropriately linked. To ensure independence and appropriate combination of outcome constructs, syntheses were conducted according to the type of interventions specified above. If multi-arm studies were included, intervention groups were combined or separated into different forest plots, and we ensured that there was no double counting of participants. If an outcome is reported in several different metrics, we performed unit conversions in order to pool the data. We anticipated differences in the types of literature, and therefore ensured that any analysis took possible sources of dependency into account by grouping papers into studies, and ensuring that no double counting of evidence took place when synthesizing across studies.

| Details of study coding categories
Three review authors (A. R., F. R., and Z. A. P.) independently extracted data in pairs, and a fourth review author (Z. L.) checked for reliability and resolved any conflict. We extracted the primary data for the study characteristics including details of the populations, setting, socio-demographic characteristics, interventions, comparators, outcomes, and study design in duplicate. We checked primary study data for accuracy.
The following information was extracted for each included study: • Background: time period when study took place, type of publication (e.g., full-text journal article, abstract, conference paper, thesis), study country or countries, • Population and setting: population age, and setting outcomes, data was extracted as mean and standard deviation (SD). If the mean and SD are not available, we converted the data by using standard methods. We also examined any published errata to assess the retraction status of the study. If a study was included with more than two intervention arms (multiarmed), we only included the arms that met the eligibility criteria.

| Assessment of ROB in included studies
Three review authors (ZAP, FR, AR) independently assessed the ROB for each included study. We resolved any disagreements by discussion or by involving a fourth review author.
For RCTs, including cluster-RCTs, we used the Cochrane Collaboration Risk of Bias tool (Higgins et al., 2011). We assessed the ROB according to the following domains. We justified the categorical ROB/study quality judgments (e.g., high, low, and unclear) with information directly from the study.
• Random sequence generation  (Higgins et al., 2011) to calculate the appropriate effect size. Where other available data were not sufficient to calculate SDs, we contacted the study authors. When we were unable to enter the results in either way, we described them in the table or entered the data into the "Additional tables" section. We also considered the possibility and implications of skewed data when analysing continuous outcomes as they could mislead results due to small sample size. We analysed outcomes from studies with multiple groups in an appropriate way to avoid double counting of participants by adding them to different subgroups within same plot. In such a scenario, we did not report the overall pooled estimate and only reported subgroup pooled estimate.

| Unit of analysis issues
We had a number of different outcomes and outcome subcategories.
Conceptually, these subcategories could not be combined (e.g., within the cognitive development, language cannot be combined with intelligence).
Therefore, a meta-analysis was conducted separately for each outcome.
Furthermore, for each outcome, we separately meta-analysed different study designs (ITS, RCT, and CBA). We reported all the effect sizes for each outcome and did not prioritize any from others.
Where trials used clustered randomizations, we anticipated that study investigators would have presented their results after appropriately controlling for clustering effects (e.g., variance inflated standard errors, hierarchical linear models). If it was unclear whether a clusterrandomized controlled trial had appropriately accounted for clustering, the study investigators were contacted for further information. Where appropriate controls for clustering were not used, we requested an estimate of the intra-class correlation coefficient (ICC). Following this, effect sizes and standard errors were meta-analysed in RevMan using the generic inverse method (Higgins et al., 2011). They were combined with estimates from individual-level trials.

| Dealing with missing data
We contacted three authors (i.e., Abdel-Aziz et al., 2018;Aşcı & Rathfisch, 2016;Ceesay et al., 1997) to verify key study characteristics and obtain missing numerical outcome data where possible (e.g., when we identify a study as an abstract only), but we did not receive any missing information from them. If we did not find a full report even after we contacted the study authors, we listed such an abstract as a "study awaiting classification." If numerical outcome data were missing, such as SDs or correlation coefficients, and we could not obtain these from the study authors, we calculated them from other available statistics, such as p values, according to the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins et al., 2011).

| Assessment of heterogeneity
Statistical heterogeneity was assessed using τ 2 , I 2 , and significance of the χ 2 test; we also assessed heterogeneity visually using forest plots.
Based on prior theory and clinical knowledge, we expected clinical and methodological heterogeneity in effect sizes in this literature.
Therefore, we attempted to explain any observed statistical heterogeneity using subgroup analysis.

| Assessment of reporting biases
If sufficient studies were found, funnel plots were drawn to investigate any relationship between effect size and study precision. Ten studies were usually considered sufficient to draw a funnel plot. As a direct test for publication bias, we compared the results extracted from published journal reports with results obtained from other sources (including correspondence). Whilst funnel plot asymmetry may indicate publication bias, this was not inevitably the case, and possible explanations for any asymmetry found were considered and discussed in the text of the review.

Synthesis procedures and statistical analysis
We prepared a matrix of all studies for each intervention which outlined all the differences in the studies, in the intervention, duration, timing, and so forth, and examined how to pool them together. Our meta-analyses were random effects meta-analyses, given the diverse contexts, participants, interventions, and so forth.
For each comparison, we descriptively summarized the findings from the contextual factors such as setting, timings of intervention, duration of intervention, people delivering interventions, and so forth, to assess their impact on the implementation and effectiveness of each intervention.

"Summary of findings" tables
We constructed "Summary of findings" tables for all of the primary outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria (GRADEpro GDT, 2015).
These covered consideration of within-study ROB (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias. We rated the certainty of evidence for each key outcome as "high," "moderate," "low," or "very low." The GRADE evidence is described in Table 1. Nonrandomized studies were initially rated as "low" quality. If there were no serious methodological flaws, we upgraded the evidence for studies with a large magnitude of effect; presence of a dose response relationship; and effect of plausible residual confounding.
We used GRADE and prepared the summary of findings tables on the following primary outcomes: • Stillbirth defined as baby born with no signs of life at or after 28 weeks' gestation • Perinatal mortality (stillbirth and deaths ≤7 days) • Neonatal mortality (death <28 days) • Infant mortality (deaths between 0 and 12 months) • Under-five mortality (deaths between 0 and 59 months) • Miscarriage • Mean maternal BMI

| Subgroup analysis and investigation of heterogeneity
We conducted the following subgroup analyses on primary outcomes when there were enough studies in each subgroup. The following subgroups would help in differentiating the impact of nutritional interventions for women based on their nutritional status, geographical location and settings, and duration of supplementation. This would aid in implementing interventions for specific population.

| Sensitivity analysis
If numbers permitted, sensitivity analyses was performed on the primary outcomes to consider the impact of the following.
• Allocation concealment (adequate versus inadequate and/or unclear) • Attrition (<10% vs. ≥10%) • Imputed inter correlation coefficients (ICC) that have been derived in different ways 4.3.14 | Treatment of qualitative research Qualitative research was outside the scope of this review. Fifteen studies were finally included for data extraction and meta analysis (see Figure 2).
Intervention. The studies on BEP assessed macronutrient supplementation in various forms. For example, Ceesay et al. (1997) and Prentice et al. (1987) provided BEP in the form of biscuits, while other studies provided it in the form of energy.
All studies provided supplementation during pregnancy, however, the timing and duration of supplementation varied from the discovery of pregnancy to the last trimester of pregnancy. Kaseb et al. (2002) implemented comparatively early supplementation starting at the 4th month of pregnancy. One study provided supplementation throughout pregnancy (Dwarkanath et al., 2016). Three studies began supplementation at 20 weeks of gestation (Ceesay et al., 1997;Ross et al., 1985;Tontisirin et al., 1986). One study began supplementation at 24 weeks of gestation (Prentice et al., 1987), and two studies began supplementation in the last trimester of pregnancy (Girija et al., 1984;Mora et al., 1978a).
Four of the BEP studies involved daily supplementation (Ceesay et al., 1997;Dwarkanath et al., 2016). Two studies involved supplementation five times a week (Kaseb et al., 2002;Ross et al., 1985). Prentice et al. (1987) instructed the use of supplements six times a week. Participants in Tontisirin et al. (1986) were instructed to consume the supplement three times a day in addition to their normal home meals. While two studies failed to report on it (Girija et al., 1984;Mora et al., 1978a).
The interventions took place in varying combination of slums, communities, hospitals, and villages. Three studies provided intervention in community (Frith et al., 2015;Johnson et al., 2016;Mridha et al., 2016), one in hospital (Ashorn et al., 2015), and one study failed to mention the setting (Leroy et al., 2016).
Three studies were conducted in rural setting (Ashorn et al., 2015;Frith et al., 2015;Johnson et al., 2016), and one study failed to mention sufficient detail on the setting (Leroy et al., 2016).
Participants. All participants were healthy pregnant women of child bearing age with no comorbids. The age range of pregnant females for shorter duration (Frith et al., 2015), and one received bonus community and general health education (Leroy et al., 2016).

Interventions for obesity prevention
Two trials were included in the interventions for obesity prevention (Aşcı & Rathfisch, 2016;Liu et al., 2017). The interventions included dietary and lifestyle counseling aimed at preventing or reducing the risk of obesity.

Settings.
Of these included studies, one was from Asia: China (Liu et al., 2017), and one study was from Europe: Turkey (Aşcı & Rathfisch, 2016).
The study interventions took place in a tertiary health care center (Liu et al., 2017), and one in a family healthcare center (Aşcı & Rathfisch, 2016; Table 2).
None of the studies reported sufficient information to judge the level of infrastructure (i.e., urban or rural) of the study setting.
Participants. All participants were healthy pregnant women with no additional comorbid conditions. The mean age of pregnant females was 25.5 years. Both studies included healthy normal weight women.
Study population was only reported by one study (Aşcı & Rathfisch, 2016) with 21,000 people, whereas the other study failed to report on study population (Liu et al., 2017).
Intervention groups. Intervention for obesity prevention included dietary interventions along with nutrition education, counseling sessions on healthy lifestyle and behavioral change (Aşcı & Rathfisch, 2016;Liu et al., 2017). (2016) and Liu et al. (2017) provided participants with the standard-of-care.

Randomized control trials
One RCT was related to intervention for obesity prevention (Aşcı & Rathfisch, 2016).

| Allocation (selection bias)
BEP supplementation Sequence generation. Adequate randomization was done in one trial (Ceesay et al., 1997), due to which the ROB was low. Stratified design according to the village size was used for random sequence generation (Ceesay et al., 1997).
Two trials had high risk for sequence generation (Kaseb et al., 2002;Tontisirin et al., 1986). In Kaseb et al., (2002) and Tontisirin et al. (1986), the experimental and control groups were selected sequentially which led to an increased predictability among personnel and participants making the ROB high. The randomization method was not clearly mentioned in two trials (Dwarkanath et al., 2016;Ross et al., 1985), making the ROB unclear.
Allocation concealment. The ROB for allocation concealment was high in one trial (Kaseb et al., 2002), because participants were selected sequentially by the women referred to the health care of Ghaemieh and Baghfayz. The method of allocation concealment was not clearly mentioned in four trials (Ceesay et al., 1997;Dwarkanath et al., 2016;Ross et al., 1985;Tontisirin et al., 1986), making the ROB unclear. Allocation concealment. ROB was low for allocation concealment in two studies. It was low because of use of opaque, sealed envelopes (Ashorn et al., 2015), and numbered boxes (Johnson et al., 2016). The ROB for allocation concealment was unclear in three trials (Frith et al., 2015;Leroy et al., 2016.

Food distribution program
Blinding of participants and personnel. One RCT (Ashorn et al., 2015) was at low risk due to adequate blinding or because blinding was not required due to the type of intervention occurring. Two RCTs which did not mention blinding of participants/personnel distinctly were at unclear ROB (Frith et al., 2015;Leroy et al., 2016).
There was a high ROB concerning blinding in two trial as the interviewers were not blinded to the interventions that the women in different arms of the trial would be receiving (Johnson et al., 2016;Mridha et al., 2016).
Blinding of outcome assessors. Three of the trials were at low ROB because they had performed adequate blinding of outcome assessors (Ashorn et al., 2015;Johnson et al., 2016;Mridha et al., 2016). Two trials did not mention blinding of outcome assessor and hence, had an unclear ROB (Frith et al., 2015;Leroy et al., 2016).

Interventions for obesity prevention
Blinding of participants and personnel. One trial reported to perform adequate blinding of participants and personnel (Aşcı & Rathfisch, 2016).

BEP supplementation
Incomplete outcome data. Studies that were at low risk addressed incomplete outcome data adequately in three studies (Ceesay et al., 1997;Dwarkanath et al., 2016;Tontisirin et al., 1986). The issue of incomplete outcome data was not addressed adequately in one trial (Kaseb et al., 2002) putting it at an unclear ROB. Two studies were at high risk of attrition bias due to significant loss to follow-up from both intervention and control groups (Ross et al., 1985).

Food distribution program
Incomplete outcome data. This issue was addressed reasonably well due to low attrition rates by one study (Ashorn et al., 2015). The issue of incomplete outcome data was not addressed adequately in one trial LASSI ET AL.
| 17 of 66 (Leroy et al., 2016) putting it at an unclear ROB. Three studies were at high risk of attrition bias due to significant loss to follow-up from both intervention and control groups (Frith et al., 2015;Johnson et al., 2016;Mridha et al., 2016).

Interventions for obesity prevention
Incomplete outcome data. One study was at high risk of attrition bias due to significant loss to follow-up from both intervention and control groups (Aşcı & Rathfisch, 2016).

Food distribution program
Selective reporting. One trial had low ROB when there was sufficient evidence to disregard the notion of selective reporting (Frith et al., 2015), and one had unclear ROB when there was not (Johnson et al., 2016). Two trials were at high risk because they were unable to report all the outcomes mentioned in the protocol (Ashorn et al., 2015;Leroy et al., 2016).

Interventions for obesity prevention
One trial had unclear ROB as there was insufficient evidence to disregard the notion of selective reporting (Aşcı & Rathfisch, 2016).

Interventions for obesity prevention
One study on obesity prevention was free from other sources of bias (Aşcı & Rathfisch, 2016).

Food distribution program
There were no quasi experimental trials related to FDP.

Interventions for obesity prevention
There was only one quasi experimental trial on interventions related to obesity prevention in pregnant women (Liu et al., 2017).
5.2.10 | Was the allocation sequence adequately generated?

Interventions for obesity prevention
Adequate randomization was done in one trial (Liu et al., 2017), due to which the ROB was low.

BEP supplementation
Two quasi experimental studies did not conceal allocation adequately, making the ROB high (Girija et al., 1984;Mora et al., 1978b).
The ROB for allocation concealment was unclear in one trial (Prentice et al., 1987) as it was not mentioned in the respective text.

Interventions for obesity prevention
The ROB for allocation concealment was unclear in the only included obesity prevention trial (Liu et al., 2017) as it was not mentioned in the respective text.
5.2.12 | Were baseline outcome measurements similar?

BEP supplementation
Baseline outcomes were similar across groups in one trial in BEP supplementation program (Prentice et al., 1987). Two trials failed to report on it making the ROB unclear (Girija et al., 1984;Mora et al., 1978b).

Interventions for obesity prevention
Baseline outcomes were similar across groups in the only trial in obesity prevention program (Liu et al., 2017).

BEP supplementation
Baseline characteristics were similar across groups in one trial (Prentice et al., 1987) in BEP supplementation program. Two trials failed to report on it making the ROB unclear (Girija et al., 1984;Mora et al., 1978b).

Interventions for obesity prevention
Baseline characteristics were similar across groups in one trial (Liu et al., 2017) in obesity prevention program.
5.2.14 | Were incomplete outcome data adequately addressed?

BEP supplementation
One trial was at low risk addressing incomplete outcome data adequately (Prentice et al., 1987) on BEP supplementation, while two trials failed to report on it making the ROB unclear (Girija et al., 1984;Mora et al., 1978b).
Liu et al., 2017 had a substantial attrition rate with 10.9% attrition as 11 of the 101 participants were lost to follow-up.

5.2.15
| Was knowledge of the allocated intervention adequately prevented during the study?

BEP supplementation
In one trial, there was an unclear ROB with regards to prevention of knowledge of the allocated interventions (Prentice et al., 1987), while two studies failed to prevent knowledge of the allocated interventions, making the ROB high (Girija et al., 1984;Mora et al., 1978b).

Interventions for obesity prevention
There was an unclear ROB with regards to prevention of knowledge of the allocated interventions in one trial (Liu et al., 2017).

| Was the study adequately protected against contamination?
Balanced energy protein Adequate measures were taken in one trial (Prentice et al., 1987) with regards to contamination, while two trials failed to take measures, making the ROB high (Girija et al., 1984;Mora et al., 1978b).

Interventions for obesity prevention
With regards to contamination, there was insufficient data to make a judgment in one case (Liu et al., 2017).

5.2.17
| Was the study free from selective outcome reporting?

BEP supplementation
Three trials on BEP supplementation had unclear ROB since there was insufficient evidence to disregard the notion of selective reporting (Girija et al., 1984;Prentice et al., 1987;Mora et al., 1978b).

Interventions for obesity prevention
One trial was at unclear risk of selective outcome reporting (Liu et al., 2017) in obesity prevention studies.

| Was the study free from other risks of bias?
Balanced energy protein Three trials (Girija et al., 1984;Prentice et al., 1987;Mora et al., 1978b) on BEP supplementation were free from other sources of bias.

Interventions for obesity prevention
The one trial (Liu et al., 2017) on obesity prevention was free from other sources of bias.

Maternal outcomes
Studies on BEP supplementation failed to report on maternal outcomes (i.e., maternal BMI).

Maternal outcomes
The BEP trials failed to report on maternal secondary outcomes including maternal mortality, pre-eclampsia, placental abruption, overweight, obesity, anemia, and iron deficiency anemia. The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
c Since mortality is a not frequently occurring outcome, so we mark it as serious.
d Allocation concealment, blinding of personnel, participants and outcome assessor is unclear. e p value is .008, which shows existence of heterogeneity. f p value is .08, which shows existence of heterogeneity.
LASSI ET AL.

Fetal outcomes
The BEP trials failed to report on fetal secondary outcomes, that is, congenital anomalies.

Newborn outcomes
The included studies on BEP intervention failed to report on macrosomia as an outcome.

Child outcomes
The included studies on BEP failed to report on stunting, wasting, underweight, developmental outcomes, respiratory disease, allergic disease, hemoglobin concentration, and iron deficiency anemia in children. We included five trials (Ashorn et al., 2015;Frith et al., 2015;Johnson et al., 2016;Leroy et al., 2016;Mridha et al., 2016), involving a total of 46,442 participants to study the effect of FDP in pregnancy on neonatal and maternal outcomes.
Included studies on FDP failed to report on any other primary outcomes including maternal BMI and under-five mortality.

Maternal outcomes
None of the included trials on FDP reported on mean maternal BMI.

Fetal and newborn outcomes
Miscarriage. One study    Tables 3 and 7).
Perinatal mortality. Two studies (Ashorn et al., 2015;Mridha et al., 2016) reported on perinatal mortality, which showed that FDP may reduce the incidence of perinatal mortality by 33% (RR, 0.67; 95% CI, 0.41-1.09, two studies, 4852 participants; heterogeneity: χ 2 = 0.29, I 2 = 11%, low quality on GRADE) (Analysis 6.2; Figure 5; The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). b The study is at high risk of blinding of participants and personnel, incomplete outcome data and selective reporting. It was unclear for allocation concealment. participants; heterogeneity: χ 2 p = .79, I 2 = 0%) (Analysis 6.5).

Fetal outcomes
Studies on FDP failed to report on congenital anomalies.

Newborn outcomes
Studies on FDP failed to report on newborn outcome of macrosomia.

Child outcomes
The studies failed to report on the secondary outcomes of developmental outcomes, respiratory disease, allergic diseases, hemoglobin concentration, and iron deficiency anemia in children.

| Comparison 3: Interventions for obesity prevention versus control
Two studies (Aşcı & Rathfisch, 2016;Liu et al., 2017), including 192 participants, targeted on prevention of obesity among pregnant women through dietary interventions and lifestyle modifications.

| Primary outcomes
None of the studies have reported any data on the effect of supplementation on primary outcomes, namely maternal BMI, miscarriage, stillbirths, perinatal mortality, neonatal mortality, infant mortality, and under-five mortality.

Maternal outcomes
None of the included obesity prevention trials have reported any data on the effect of supplementation on maternal outcomes, namely maternal mortality, pre-eclampsia, placental abruption, anemia, overweight, obesity, and iron deficiency anemia.

Fetal outcomes
No fetal outcomes were reported by the obesity prevention trials.

Newborn outcomes
The obesity prevention studies failed to report preterm birth, LBW, SGA, and head circumference of newborns.

Child outcomes
No child outcomes were reported by the obesity prevention trials.

| Sensitivity analysis
Allocation concealment BEP supplementation. Sensitivity analysis was conducted on BEP trials prejudicing for unclear risk of selection bias. We conducted sensitivity analysis on primary outcomes for allocation concealment by removing Mora et al. (1978b) due to high risk of allocation concealment. No significant change was observed in stillbirths after removing Mora et al. (1978b).
Food distribution program. Sensitivity analysis was conducted in FDP trials prejudicing for unclear risk of selection bias and none of the FDP trials were excluded as a result.
Interventions for obesity prevention. We were unable to conduct sensitivity analysis on trials of obesity prevention since no primary outcomes of our interest were reported in the included studies.
Attrition bias BEP supplementation. All BEP trials reporting primary outcomes reported attrition rates below 10%, clearing them of attrition bias. Thus sensitivity analysis was not performed on BEP trials to study the impact of attrition bias.
Food distribution program. We excluded Mridha et al. (2016) while performing sensitivity analysis to consider the impact of attrition bias, and no significant shifts were experienced in the overall findings of perinatal mortality.
Interventions for obesity prevention. Sensitivity analysis could not be performed for any obesity prevention outcomes in any capacity as the trials did not investigate any of the primary outcomes of the study. Interventions for obesity prevention. Sensitivity analysis could not be performed for obesity prevention outcomes in any capacity as the trials did not investigate any of the primary outcomes of the study.

| Summary of main results
We included a total of 15 trials involving healthy pregnant women from LMICs. Eight studies evaluated the impact of BEP supplementation (25% of energy provided by protein), five on FDP, and two on obesity prevention program. This review summarized the current evidence on the effect of dietary interventions during pregnancy on maternal, neonatal, and child outcomes.
BEP supplementation may reduce incidence of stillbirths by 61%, perinatal mortality by 5%, LBW infants by 40%, SGA by 29%, and increased birth weight by 107.28 g. An increase of 107.28 g of birthweight is clinically significant in the countries where the intervention has been provided. BEP supplementation had no effect on miscarriage, neonatal mortality, infant mortality, preterm birth, birth length, and head circumference. Sensitivity analysis was conducted for primary outcomes on allocation concealment, attrition bias, and ICC. The subsequent exclusion of a study for sensitivity analysis of allocation concealment did not result in a significant change of outcome of stillbirths, however, sensitivity analysis for ICC resulted in a significant change in results.
There was no effect of attrition bias on the sensitivity analysis.
FDPs showed an improvement in mean birth weight by 46 g, birth length by 0.20 cm, and reduction in stunting by 18%, and wasting by 13%. No improvements were observed for miscarriages, maternal mortality, perinatal mortality, neonatal mortality, infant mortality, LBW, preterm birth, SGA babies, mean head circumference, and rates of underweight babies. For sensitivity analysis, all trials were unclear for selection bias therefore none of them were excluded. Sensitivity analysis for attrition bias and ICC resulted in no significant change in the findings of perinatal mortality.
Trials on counseling on lifestyle modification for pregnant women on obesity prevention failed to report on the primary outcomes but did show a significant 195.57 g reduction in mean birthweight and had no effect on mean birth length, and macrosomia. A sensitivity analysis could not be conducted for this comparison.

| Overall completeness and applicability of evidence
An extensive search was done to locate relevant papers on multiple search engines outlined. The reference lists of included studies and reviews were searched as well. Data was extracted and quality was assessed in duplicate. Differences were discussed and resolved between the authors, and where needed a fourth author was consulted. The quality of selected outcomes was also assessed using GRADE analysis.
This review summarized findings from 15 studies. These studies were conducted in LMICs, particularly in Africa, Asia, Central and South America. BEP supplementation appeared to be effective in improving rates of stillbirth, perinatal mortality, LBW, SGA, and birth weight, whereas FDP was found to improve birth weight, birth length, stunting, and wasting. The obesity prevention studies were few in number but demonstrated a significant reduction in mean birth weight. We also conducted a sensitivity analyses to assess the effects by removing trials that imputed inter-correlation coefficients through different ways; and the results show a significant change in the estimates. However, the included studies were conducted among healthy pregnant women in LMICs, thus these results cannot be generalized in high income countries.

| Quality of the evidence
We judged the quality of the evidence of the individual studies by utilizing ROB assessment tool for RCTs and cRCTs, and EPOC for quasi experimental trials. GRADE methodology was used to assess the quality of evidence for the primary outcomes. We also conducted a sensitivity analysis for outcomes with high risk of allocation concealment, attrition bias, and imputed inter-correlation coefficients, and analysed the change in estimate.
In BEP, the overall quality of evidence for infant mortality was moderate, however, stillbirths, perinatal mortality, neonatal mortality, LBW, and preterm birth was low to very low due to down grading for imprecision and ROB. For FDP, the overall quality of evidence for LASSI ET AL.

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all outcomes ranged from moderate to low due to downgrading for imprecision and ROB. We did not perform GRADE analysis for interventions for obesity prevention, since none of the included studies reported on the primary outcomes of our interest.

| Potential biases in the review process
Efforts were made to reduce all potential sources of bias. We conducted an extensive electronic search on the pre-specified databases.
The methodology was followed religiously as per the protocol (Lassi et al., 2019). We included 15 studies out of which eight were on BEP supplementation. To improve the quality of the study, we also performed sensitivity analysis. Also, we did not conduct a funnel plot analysis as it would have been inconclusive due to the small number of studies (each intervention/outcome comparison had fewer than 10 studies). We were unable to find systematic reviews on FDP due to the lack of a definition of a FDP. Also no such review was conducted in LMIC settings to be compared with our review.

| Agreements and disagreements with other studies or reviews
Reviews investigating obesity prevention programs in recent time were not particularly successful with Furber et al. (2013) netting no studies. One comparable review on mitigating the ex-

| Implications for research
We found limited data on effectiveness of BEP supplementation, FDP, and dietary intervention for prevention of obesity among pregnant women. Further good quality studies are required to evaluate the role and potential effect of BEP supplementation, FDP, and dietary intervention for prevention of obesity on maternal, neonatal, and child outcomes. Moreover, the effect of intervention in various population groups should also be explored for generalizability of results, and to draw authentic conclusions.

ACKNOWLEDGMENTS
We are grateful to our coordinating team of Campbell IDNG 1810 for their support in preparing this review. We would also like to acknowledge Shailja Shah for assisting in title/abstract screening, and for helping with initial steps of full text screening and data extraction.

DECLARATIONS OF INTEREST
The authors declare no conflicts of interest arising from financial or researcher interest.

DIFFERENCES BETWEEN PROTOCOL AND REVIEW
In the protocol we planned to analyse GRADE on primary outcomes inclusive of two secondary outcomes, that is, low birthweight and preterm birth. Also one of our primary outcome 'miscarriages' was missing from the list of GRADE. Thus, in this review we have analysed only primary outcomes, and have also included miscarriage on our list. We have not analysed GRADE on low birth weight and preterm birth. Family income: Not specified

Inclusion criteria:
Pregnant women who came for antenatal care at any of the study clinics during the enrolment period and met the following inclusion criteria: ultrasound confirmed pregnancy of no more than 20 completed gestational weeks, residence in the defined catchment area, availability during the period of the study and signed or thumb-printed informed consent Exclusion criteria: Age younger than 15 years, need for frequent medical attention due to a chronic health condition, diagnosed asthma treated with regular medication, severe illness warranting hospital referral, history of allergy toward peanuts, history of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care, pregnancy complications evident at enrolment visit (moderate to severe edema, blood haemoglobin concentration <50 g/L, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), earlier participation in the iLiNS-DYAD-M trial (during a previous pregnancy) or concurrent participation in any other clinical trial

Interventions
Intervention (sample size): LNS: Tailor-made SQ-LNS from enrolment to 6 months postpartum. Daily dose of 20 g to provide the same micronutrients as MMN, 4 additional minerals (calcium, phosphorus, potassium, magnesium), protein and fat providing 118 kcal of energy. Raw ingredients for LNS included soybean oil, dried skimmed milk, peanut paste, mineral and vitamin mix, and sugar. Intervention was delivered through data collectors (n = 462)

Control (sample size):
IFA: received standard antenatal care including supplementation of iron 60 mg, folic acid 400 µg from enrolment to delivery. It was delivered through data collectors (n = 463)

Concomitant interventions:
Received intermittent preventive malaria treatment, that is, 2 doses of intermittent preventive malaria treatment with sulphadoxine-pyrimethamine (3 tablets of 500 mg sulphadoxine and 25 mg pyrimethamine orally). One sulphadoxinepyrimethamine dose was given at enrolment and the other between weeks 28 and 34 of gestation Health facility nurses gave pretest HIV counselling and tested for HIV infection in all participants, except those who opted out or were already known to be HIV infected, by using a whole-blood antibody rapid test.

LNS (n = 462)
Training: Study physicians trained health providers at all the known private and public health facilities in the area to identify the study participants from their iLiNS identification cards and to record information on any nonscheduled visits on structured data collection forms that were collected and reviewed by the study team on a weekly basis

Follow-up:
Study coordinators invited the participants for follow-up at the study clinic twice during pregnancy (at 32 and 36 gestational weeks) and once after birth, at 1-2 weeks after delivery and at 6 months; post-natal followup done till 6 weeks after delivery Participants were also provided with mobile phones and airtime so that they could immediately inform the study coordinators about the deliveries (which took place outside the clinics). Upon notification the coordinator visited the site of delivery for interview and infant measurements LASSI ET AL. Large number of missing data, delays in anthropometric measurements of some participants, temporary discontinuation of LNS distribution and inability to observe consumption of study supplements. However, the smaller sample size than originally intended (due to budget reduction) limited the statistical power of the study. In preliminary analyses from the current study population, maternal malaria, HIV infection, and inflammatory response appeared associated with adverse pregnancy outcomes and also seemed to modify some of the intervention effects on them Lifestyle intervention for whole pregnancy till 6 weeks postpartum. 4 meetings were held with women regarding healthy lifestyle, nutrition, exercise, and weight follow-up. Patients were given a card on which weight, height, and gestational weight gain were recorded. The women were provided with praise and those that were not able to meet objectives had their short comings reviewed. Women who could not reach their objectives were given more intensive consultancy (repetition of basic nutrition and physical activity recommendations, reviewing individual objectives, and supportive phone consultancy) was provided. Counselling and behavioral coaching was personalized according to the barriers for individuals. Meetings were supplemented with 15 minute health training and brochures were delivered It was delivered by the first author of the study (nurse) (n = 51)

Control (sample size):
Standard of care. Consultancies mostly consist of subjects such as pregnancy complaints, scope of antenatal care, tests to be performed, birth, post-partum period, and circumstances that might pose danger during pregnancy, There is no standard training and consultancy. Women in the standard care group (control) are followed up at least four times by midwives or nurses. Every trip weights are measured. Consultancy is granted for pregnancy complaints, tests, birth and postpartum period but lifestyle advice is not granted. Duration was from 12th week pregnancy till 6 weeks postpartum. It was delivered by nurses and midwives (n = 51) LASSI ET AL.

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Training: Not specified Follow-up: Intervention group: In weeks 12-15, the focus was on healthy life and health practices. In weeks 16-18, the focus was on physical activity and exercises. In weeks 20-24, interviews regarding nutrition were held, that is, meal frequency, size, content. On week 37, only weights were followed up and target achievement was reviewed and the intervention was ended. At 6 weeks postpartum obstetric and neonatal outcomes were measured Participation in the study was stopped as soon as the sample size determined by the power analysis was obtained without taking case losses into consideration due to the time constraints for the completion of the study. This situation caused the study to be completed with a smaller sample size than planned. Intervention was applied by the same person in the study (first author of this study who was the nurse officially rendering services in the centre on the dates that the study was conducted) within official working hours. From these aspects, the intervention was strong in terms of controlling the contents of consultancy for each participant and "realistic" in terms of applicability by nurses and midwives. However, the fact that the study was conducted in only one centre and the sample group was limited to healthy pregnant women who did not intend to lose weight and had less than two pregnancies even if they were selected randomly is not sufficient for generalizing the results of the study BMI pre-pregnancy: Pregant females who received supplementation with high energy biscuits after delivery. Supplentation was delivered by two birth attendants in each village (n = 1037)

Concomitant interventions:
Both groups received: 1. Routine antenatal care (interview; abdominal palpation; blood pressure and haemoglobin and urine protein concentrations; treatment or referral as indicated) from midwives in a mobile clinic that visited each village twice monthly 2. Iron and folate supplements (according to haemoglobin concentration) 3. Tetanus toxoid to not previously protected women 4. prophylactic dose of chloroquine (in hungry season) Training: The field workers were trained in anthropometric techniques and Parkin scoring in the delivery wards of the Gambia's main hospital Only pregnant women from the same dwelling area and similar socioeconomic background were invited to join the study. Pregnant women at <13 weeks of gestation with low BMIs (≤18.5) and normal plasma folate and vitamin B-12 status were identified and invited Exclusion criteria: Women with multiple pregnancies, those with a clinical diagnosis of chronic illness (e.g., diabetes mellitus, hypertension, cardiac disease, thyroid disease, or epilepsy), and those who tested positive for hepatitis B surface antigen, HIV, or syphilis were excluded

Interventions Intervention (sample size):
In addition to their normal habitual diet, the supplemented group received a daily dietary supplement of 300 kcal/day energy and 15 g protein/day (i.e., 20% of energy from protein), provided as 3 small, round granolatype treats, called "ladoos" in the local language, and made of crushed roasted peanuts, puffed rice, skimmed milk, clarified butter, and unrefined sugar from 1st trimester till delivery. Intervention was delivered by a social worker (n = 12) Control (sample size): No supplementation. The control group continued to consume their habitual diet. It was delivered by a social worker (n = 12) Training: Not specified

Follow-up:
Protein kinetics and serine and glycine fluxes were measured by using standard stable isotope tracer methods in the fasting and postprandial state at end of 1st and beginning of 3rd trimester. 24-h food recalls were obtained three times during each trimester of pregnancy Early Supplementation:The supplement contained rice, lentils, molasses and oil, contained 2.5 MJ per day, 6 days a week (29% of recommended energy intake), 25% of which was vegetable protein from 9 weeks of pregnancy to birth to 6 months postpartum. Intervention was delivered by community nutrition educators (n = 533) Control (sample size): Usual start of joining of government food supplementation. The supplement contained rice, lentils, molasses and oil, contained 2.5 MJ per day, 6 days a week (29% of recommended energy intake), 25% of which was vegetable protein. Duration of supplementation was from 20 weeks of pregnancy to birth to 6 months post partum. Intervention was delivered by community nutrition educators (n = 508)

Concomitant Interventions:
Each participant was also assigned to receive one of two counselling protocols from 30 weeks of gestation until 6 months after giving birth as follows: either usual health messages alone or usual health messages with exclusive breastfeeding counselling.
Beginning at 14 weeks of gestation until 3 months post-partum, each participant received one of three daily micronutrient supplements of either 60 mg or 30 mg of iron with 400 mg folic acid or multiple micronutrients Training: Community nutrition educators were trained by the implementing organisation, BRAC, to deliver nutrition education messages and to encourage women to consume food packets completely on site

Follow-up:
Daily follow-ups were conducted for salivary cortisol level monitoring but that is not relevant to our review. Measured cortisol from 28 to 32 weeks of gestation. Birth weight measured between one day of birth Inclusion criteria: Pregnant women, belonging to a low socioeconomic group with a monthly family income of less than Rs. 700 (US$100) and who were in the last trimester of pregnancy were selected Exclusion criteria: Not specified

Interventions
Intervention (sample size): The supplement consisted of 50 g of sesame cake, 40 g jaggery and 10 g oil. The supplement contributed 30 g protein and 417 kCals (n = 533)

Concomitant interventions: None
Training: Not specified Exclusion criteria: Women who were (i) currently pregnant (beyond 20 weeks on ultrasound assessment), (ii) currently enrolled in another MRC study, (iii) severely anaemic at booking (haemoglobin (Hb) <7 g/dl), or (iv) report the onset of menopause were excluded from entry into the trial

Interventions
Intervention (sample size): Protein Energy (PE) provided with 746 kcal/day of energy from protein and lipids. It was provided to pregnant women between 10-20th week of gestation. LNS was distributed on a weekly basis to participating women. LNS were supplied in jars, with a single (daily) dose per jar. It was provided through field workers and midwives (n = 151)

Control (sample size):
FeFol (iron 60 mg/day and folic acid 400 μg/day) was given as a prenatal care. It was provided to pregnant women between 10-20th week of gestation. It was provided through field workers and midwives. Supplementation commenced the following week, receiving daily tablet supplements. Both supplement types (tablets and LNS) were distributed on a weekly basis to participating women. Women were supplied with 14 tablets per week in individual bottles and advised to take two tablets per day, preferably with food (n = 146)

Concomitant interventions: Not specified
Training: Prior to the start of the study, two sonographers were trained in fetal biometry The food component aimed to increase household food security in terms of both quantity and quality (through a family ration containing micronutrient-fortified foods) and maternal and child nutrition (through the individual micronutrient-fortified food rations targeted at pregnant and lactating mothers and children from 6 to 24 months of age) Corn-soy blend (CSB) and fortified vegetable oil were the 2 commodities provided in household and individual rations. Intervention was delivered by tubaramure health promoters (n = 1662)

Control (sample size):
Standard care. The control group did not receive any program benefits but continued to have access to the standard care provided by the Ministry of Health (n = 843)

Concomitant interventions:
The core program package included 3 components: the distribution of food rations, improvements in the provision and use of health services, and a behavior change communication (BCC) strategy focused on improving health, hygiene, and nutrition practices Training: Repeated testing was done to assess who had acquired the required skills to conduct the fieldwork

Follow-up:
In 2012 to assess the impact on maternal and child anaemia and on maternal knowledge and practices. In 2014, anthropometric measuring was conducted in 2014 Outcomes Primary outcomes: None One limitation of our study is the lack of biomarker information to determine the etiology of anaemia in this population. In addition, the process evaluation found that some aspects of the care group sessions could have been strengthened. For example, leader mothers did not always have the required technical expertise or teaching skills to adequately transfer knowledge to beneficiary mothers. In addition, many beneficiaries were not exposed to messages on complementary feeding practices because of delays in the rollout of this BCC component This study was limited to participants at one tertiary hospital in Wuhan. The findings, however, may not be generalized to other populations in China as China is a very large country with regional cultural differences. The study period ended at 42 days postpartum which may be a limited time frame in which to promote postpartum weight management, especially because the Chinese tradition of "doing the month" is a time when food consumption for postpartum recovery is encouraged. Use of participants' self-report of their weight to calculate BMI may have led to bias in the data. Lastly, another limitation is that data about the incidence of breast-feeding was not collected and breastfeeding is associated with postpartum weight reduction BMI pre-pregnancy: Gestational age to be 20 weeks and no plans to move out of the study area during pregnancy or the following 3 y (i.e., a permanent resident of the study area).
Exclusion criteria: Pregnancy identified and registered in the CHDP program before the beginning of enrolment
Women received LNS-PL (LNSs for pregnant and lactating women) during pregnancy and the first 6 months postpartum. Ingredients included soybean oil, powdered milk, peanut paste, sugar, and multiple micronutrients (thiamin, riboflavin, niacin, vitamin B-6, vitamin B-12, vitamin D, vitamin E, zinc, copper, and selenium at twice the amount as previously used UNIMAPP formulations), LNS-PL was produced in individual 20-g sachets (LNS was 20 g/day 118 kcal per day).The intervention was delivered by LAMB-CHDP community health workers (n = 1047) Control (sample size): (1) Control group in which women were given IFA once daily during pregnancy and once every other day for 3 months post partum period (2) Child-only LNS group: women received 1 tablet of 60 mg Fe and 400 mg folic acid/d during pregnancy and every alternate day during the first 3 months postpartum and their children received LNS-C from the ages of 6-24 months (3) Child-only micronutrient group: Women received IFA daily during pregnancy and every alternate day during the first 3 months postpartum and their children received micronutrient powder from the ages of 6 to 24 months The three groups of women who received IFA during pregnancy were combined and compared with the "comprehensive LNS" arm for the analysis of birth outcomes. The supplements in control group were delivered by LAMB-CHDP community health workers and village health volunteers (VHVs) (n = 2964)

Concomitant interventions:
Monthly, the CHWs and VHVs would set classes for the discussion of child health and maternal health topics

Trainings:
Anthropometrists were trained and methods were standardized at the beginning of data collection and thereafter periodically by using methods described by (WHO MGRS)

Follow-up:
Monthly follow-up visits by the CHW to the woman's home. Follow-up during pregnancy included a home visit (at 35 weeks) by the home visit team to collect data on diet and birth preparedness and a subsequent safe delivery unit (SDU) visit at 36 week (wk) for anthropometry and to assess depressive symptoms and collect bio specimens by the SDU visit team After delivery, the study protocol required that each woman be visited within 72 h after birth. Each woman was also called at 28 weeks of gestation and every week from 36 weeks of gestation until the delivery occurred. Retrospective data on adherence to supplement use recommendations during pregnancy were collected at a later home visit at 6 week postpartum The disruption of LNS-PL supply for a period of 10 weeks, compromised the ability to investigate the full potential of LNS-PL as an intervention. Second, it was not possible to blind the women to the type of supplement provided because the supplements were very different in appearance and taste. Third, they used LMP to estimate the duration of gestation, because it was not feasible to use ultrasonography for all participants. Fourthly, they relied on the women's retrospective recollection of supplement consumption to assess adherence instead of direct observation, so the adherence data could be inaccurate. Finally, they examined effects within several different targeted subgroups, and these exploratory effect modification results need to be interpreted with caution because they examined multiple hypotheses and the study was not powered to test each potential interaction The tea was composed of 78 kcal energy, 2.9 g protein, 1.6 g fat, calcium 95 μg, vitamin C 10 mg. Maximum intake of the biscuits was limited to three 65 g biscuit and 380 g tea in the dry season and four 65 g biscuits and 380 g tea in the hungry season. Supplementation was provided every morning besides Sundays and public holidays. In Ramadan, the supplementation was carried out at night. Women were enrolled into the program as soon as their pregnancy was discovered and so the average duration of supplementation was 24 weeks. The supplements in the intervention arm were delivered by villagers (n = 200)

Control (sample size):
Pre-Supplementation group: All subjects had daily access to a sophisticated level of healthcare provided by a resident midwife and paediatrician. All women were provided 6 weekly follow-up at antenatal and postnatal clinics. This care included: monitoring of vitals, fetal growth, fetal heart rate, fetal presentation, immunization against tetanus, screening urine for infection and screening blood for anaemia and malaria. All women were also provided with 47 mg ferrous sulphate and folate. Major obstetrical difficulties were referred to the hospital for delivery. The supplements were delivered by villagers (n = 185)

Concomitant interventions:
All healthcare provided to the control group was also provided to the intervention group as a baseline Training: Midwives were trained to assist traditional birth attendants

Follow-up:
All women were provided 6 weekly follow-up at antenatal and postnatal clinics. This care included: monitoring of vitals, fetal growth, fetal heart rate, fetal presentation, immunization against tetanus, screening urine for infection and screening blood for anaemia and malaria Group 3 (high bulk supplements)-mixture of beans and maize in a 1.2:1 ratio as mush with added vitamins. Protein: 36 g vegetable, 3247 kJ energy, 40 mg ascorbic acid (n = 31) Group 4 (low Bulk supplement)-a porridge containing 100 g dry skimmed milk, maize flour, vitamins and minerals. It differed from the group 3 supplement in its 36 g of animal protein and in its higher levels of several vitamins and calcium. Protein: 36 g animal, 8 g vegetable, 2927 kJ energy (n = 31) The supplement was provided from the 20th week of pregnancy until delivery (Monday through Friday) Control (sample size): Group I: No supplementation provided (n = 33) Group 2: Zinc supplementation provided (30-90 mg zinc gluconate daily) (n = 32) The supplement was provided from the 20th week of pregnancy until delivery (Monday through Friday)

Concomitant interventions:
All of the women in the study had routine medical care in the Kwa-Mashu antenatal clinic

Trainings: Not specified
Follow up: The analyses performed on maternal serum at the mid-gestational entry into the study were repeated at delivery on both maternal and cord blood sera. Body weights were recorded on newborns

Outcomes
Primary outcomes: None Women on the low bulk supplement likely consumed more energy on a 24 h basis than those in the other categories. Those on the low bulk supplement claimed that the supplement did not reduce the amount they ate at other meals while those on the high bulk supplements often found they were "overfilled" by the supplement and therefore ate a smaller than normal evening meal Supplemented groups (I and II): Group I: received a mix of soybean, mungbean, sesame and sugar coming to, on average, 384 kcal energy, 9.1 g fat and 15 g protein Group II: received a mix of rice, dried shrimp, groundnut, sugar and oil coming to, on average, 348 kcal energy, 15.6 g fat and 13.1 g protein The supplement was instructed to be consumed as an additional snack and was initiated from the 28th (±2) week of gestation and stopped at birth

Control (sample size):
Nonsupplemented group (III): Group III: Did not receive any supplementation LASSI ET AL. Primigravidae aged between 20 and 30 years in their first trimester (<12 weeks of gestation) of pregnancy, attending the selected "Antenatal Care" clinic, free from history of any chronic medical problems were recruited to participate Exclusion criteria: Women younger than 18 years (to avoid natural linear growth), having the history of previous abortion or stillbirth, presence of any chronic disease, and taking any type of medications that might interfere with the body weight (steroids, diuretics and thyroid hormones)

Interventions
Intervention (sample size): Received standard of care and attended six extra counselling session with a nutrition counsellor and fortnightly face-to-face appointments for a duration of 9 months.
Intervention was delivered through a nutrition counsellor.
(n = 75) Control (sample size): Participants of the control group received the standard maternity care. Women in standard care attended their regularly scheduled visits for a duration of 9 months.
Intervention was delivered through a nutrition counsellor (n = 72) Training: Not specified

Follow-up:
Women received standard nutrition counselling provided by the physicians and nurses based on the Maternal and child Health Program components along with prenatal care from 28 weeks of gestation till delivery